Home » Medical Products Articles » West Virginia Alone Holds Big Pharma to Its Duty to Warn the Public
West Virginia Alone Holds Big Pharma to Its Duty to Warn the Public
In West Virginia, pharmaceutical companies have a duty to educate consumers directly about drug warnings.
June 10, 2010 /Medical Products PR News/ -- Problems with bone-building drugs like Fosamax, Boniva, Actonel and Reclast continue to make the news. While they are touted as drugs that prevent or treat osteoporosis, they may actually be weakening certain areas of the body when used for extended periods of time. Were patients properly warned about the side effects of these medications before taking them, either by their doctors or the manufacturing pharmaceutical companies?
In West Virginia, the duty for a pharmaceutical company to educate consumers directly about drug warnings is behind the common law elimination of the learned intermediary doctrine. West Virginia is the only state that removes this defense for large pharmaceutical companies when they are sued. This is an important factor for patients who sue these manufactures for injuries from defective drugs in West Virginia.
Osteoporosis Medications
The Food and Drug Administration (FDA) recently issued a statement communicating the safety issues reportedly linked to various osteoporosis drugs. As a group medically known as oral bisphosphonate medications, the drugs may put patients at a greater risk for upper leg breaks called atypical subtrochanteric fractures. These injuries occur in the femur bone just below the hip.
The FDA advised it is still investigating whether there is a link between the drugs Fosamax, Boniva, Actonel and Reclast and the fractures. Regardless, the bad news in the media has already spread, even as commercials and ads for the drugs continue to run.
Drug Advertising and Warnings
It is common practice for pharmaceutical manufacturers to engage in direct-to-consumer advertising, through both television and print sources, to persuade patients to request drug prescriptions by name. Once a consumer receives a prescription for a drug (Fosamax, for example), drug companies assume the patient already knows its warnings and possible side effects, either from its label or the doctor who prescribed it. While the Fosamax warning does inform users about the risk of a sudden upper-leg fracture, this message is hidden in medical jargon a typical patient may not understand.
If a patient sued Merck, the maker of Fosamax, in West Virginia, would the medication's label warning be sufficient, or should the doctor as the agent for the drug company have warned the patient about Fosamax's potentially harmful effects? This is where the issue of the learned intermediary doctrine enters the picture.
Learned Intermediary Doctrine
In general, manufacturers have a duty to warn consumers about possible defects or dangers in using their products. In most state courts, however, there is an exception for drug makers called the learned intermediary doctrine. This doctrine, which must be raised as a liability defense by the defendant pharmaceutical company in a lawsuit, basically transfers a drug manufacturer's obligations to warn patients about risks associated with taking a particular medication to the prescribing doctors, as long as it gave them sufficient warning information to pass on to their patients.
This transfer of obligation impacts the types of actions that people injured by prescription drug use can bring against the pharmaceutical companies. Outside of West Virginia, people who directly sue the drug makers under state product liability laws for defective drugs because of a failure to properly warn of its dangers may end up having their claims thrown out. This happens if the court supports the company's defense to liability according to the learned intermediary doctrine.
Patients may try to bring another products liability lawsuit against the pharmaceutical companies for a failure to adequately warn the doctors as their agents, to get around the learned intermediary doctrine defense, or choose to sue the doctors for medical malpractice or other personal injury claims, such as wrongful death. Based on a West Virginia court decision to reject the learned intermediary doctrine, however, victims of defective drugs in that state now have more legal rights and options.
West Virginia Stands Alone
The learned intermediary doctrine seems to be generally recognized in most states, even though there is a lack of consensus on the number of courts or legislatures that have officially adopted it. West Virginia is the only state court to have blatantly denied its application, however. In the case of State ex rel. Johnson & Johnson Corp. v. Karl in 2007, the West Virginia Supreme Court of Appeals offered that "as a matter of first impression, the learned intermediary doctrine would not be adopted to excuse prescription drug manufacturers from the general duty of manufacturers to warn consumers about the risks of their products."
Most West Virginia patients do not want to sue their doctors unnecessarily over their role when the pharmaceutical companies were at fault for manufacturing defective drugs or issuing inadequate warnings. Victims of injury or death caused by prescription drug use in West Virginia appreciate the court's ruling in 2007. Since this decision, consumers have been able to hold drug makers accountable for their duty to directly warn prescription drug users about possible side effects. Over time, West Virginia's approach may cause drug companies to stop putting patients at risk for serious injury due to their failure to fulfill their duties to the public.
Accountability for Big Pharma
As a patient or consumer, it is difficult to be well versed in the benefits and side effects of prescription medications, like drugs that treat osteoporosis. For doctors, who typically have a duty to oversee the care of their patients, writing prescriptions for particular drugs may lead to unforeseen patient issues. Pharmaceutical companies make the scenario more complicated by marketing directly to consumers, hoping that all the information in their ads or commercials will be enough to educate them about drug warnings and side effects.
If you or a family member is currently taking a prescription drug, such as an osteoporosis medication like Fosamax, Boniva, Actonel or Reclast, and was recently injured, you may have questions about your or your family member's legal rights and options. Contact a local West Virginia attorney with experience in defective drug cases today. A lawyer may be able to help in recovering damages for pain and suffering and to aid in paying past or future medical bills related to the injury. You have a right to hold big pharmaceutical companies to their duties to warn consumers about possible issues with their prescription medications.
Article provided by The Bell Law Firm PLLC
Visit us at www.belllaw.com
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